Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 30 Years|
Inclusion Criteria:Participants must fulfill all of the following criteria to be eligible for inclusion in the study:
- - Male and female subjects with Crohn's disease (CD), 18-30 years of age and otherwise in good health as determined by medical history and physical examination - Subjects weighing 25kg or more - History of recently diagnosed (within 12 months) ileal or ileal-colonic CD that is mild-to-moderate in severity as determined by standard history, physical, endoscopy scoring results, CD Activity Index (CDAI); patients with severe disease, which can be rapidly progressive and result in gastrointestinal hemorrhage, intestinal fistulas, abscesses and other complications, will be excluded because their risk of requiring rescue medications including steroids and biologicals as well as hospitalization or surgery are high.
- - The subject is able to swallow the required capsules and tablets.
- - The subject has been immunized according to the guidelines set forth by the CDC.
- - The subject agrees to participate in the study.
- - Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
- - Evidence of inflammation on colonoscopy with an SES-CD >3.
- - Either an elevated fecal calprotectin or an elevated CRP.
- - Willing and able to undergo upper endoscopy and colonoscopy with disease flares and after 6 months of treatment for the assessment of disease as per the standard of care for CD.
- - Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:Subjects will be excluded from the study if any of the following apply:
- - Patients with severe disease as determined by CDAI, or SES-CD scores at initial endoscopy of greater than 16, or strictures or large ulcerations on endoscopy that exemplify severe disease.
- - Acute febrile illness within 1 week before administration of study therapeutic formula.
- - Any history of other systemic diseases that, in the investigator's opinion, would preclude the subject from participating in this study, e.g. other autoimmune disease, neoplasm, HIV or hepatitis infection.
- - Abnormal hepatic function (ALT, AST or bilirubin >2 x upper limit of normal).
- - Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3).
- - Abnormal renal function (BUN and creatinine >1.5 x upper limit of normal for age or abnormal eGFR for age and race).
- - Clinically significant abnormal electrocardiogram.
- - Participation in another experimental therapy study within 30 days of this study.
- - History of alcohol or drug abuse.
- - Pregnant or lactating female subjects: females of childbearing potential will need a negative pregnancy test at screening and at each visit to be considered and continued in this study.
- - Use of intravenous or oral systemic steroids within the past six months or any use of immunomodulators or biologic medications, since these drugs have lasting effects and alter the subject's cytokine profile thus affecting the results of the study.
- - Active perirectal disease including fistuli or abcesses.
- - Use of any other CAM products.
- - Known allergy to FAHF-2/B-FAHF-2 or any of its components.
- - Concurrent use of any medications known to alter CYP3A function.
- - Any other medical concerns not listed above that in the invistigator's opinion may pose additional risks, interfere with adherence, or impact the quality or interpretation of the data.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Icahn School of Medicine at Mount Sinai|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|David Dunkin, MD|
|Principal Investigator Affiliation||Icahn School of Medicine at Mount Sinai|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
The study team's current proposed study uses the same investigational agent, B-FAHF-2, being studied for food allergy under an active IND, and seeks to determine if this formula is safe for the treatment of mild-to-moderate CD. The study team's major goal focuses on safety, tolerability, beneficial immunomodulatory effect, and preliminary clinical efficacy of B-FAHF-2 to maintain remission in subjects with mild-to-moderate CD. B-FAHF-2 is currently undergoing a phase II clinical trial for treatment of food allergy, thus increasing the ease of obtaining an FDA IND for B-FAHF-2 use in CD. Preliminary data were generated in the study team's ongoing FAHF-2 and B-FAHF-2 studies on food allergy and IBD. In developing a botanical drug from a traditional Chinese medicine (TCM) formula, standardization of product is key to ensure safety, consistency, and potency. An IND for B-FAHF-2 has been accepted by the FDA, and is documented that the product's quality, safety and standardized methodology have been demonstrated. To date, the study team has demonstrated the safety of B-FAHF-2 in animal models and the safety and tolerability of B-FAHF-2 in patients, including adults and children with food allergy. The most specific data relevant to this proposal are the suppression by FAHF-2/B-FAHF-2 of TNF-alpha production by PBMC's and intestinal specimens from children with CD and the abrogation of colitis in a murine model. CD is a life-long chronic, relapsing, immune mediated inflammatory disease characterized by inflammation in the gastrointestinal tract. Treatment is aimed at controlling mucosal inflammation, and thus symptoms of the disease, by inducing and then maintaining remission. Since CD causes abdominal pain, decreased appetite, malabsorption and diarrhea, children are particularly vulnerable because inadequate nutrition can lead to potentially irreversible growth stunting and delayed maturity. There is a lack of maintenance therapies for children and adults with mild-to-moderate disease since many of the medications used to treat CD. including steroids, immunomodulators and biological therapies are geared towards treating moderate-to-severe disease. The most commonly used medications for treatment and maintenance of remission in mild-to-moderate CD are 5-ASA compounds and antibiotics but they are not FDA approved and the literature does not support their utility in CD. Based on the inhibition of TNF-alpha by B-FAHF-2 and FAHF-2 in vitro, the study team hypothesizes that B-FAHF-2 will be safe and effective therapy that will fill this therapeutic void. The study team proposes to test the safety and tolerability of B-FAHF-2 in subjects with recently diagnosed mild-to-moderate CD that responds to induction with Entocort EC. To minimize any potential risk by exposing a large number of subjects to treatment: the study team will conduct the study in subjects 18-30 years old to assess for safety, tolerability and determine immunological and/or efficacy signals (subjective and objective measures). Since B-FAHF-2 is likely to be slow to work, subjects will be induced with Entocort EC for 8 weeks. Responders will then be enrolled in the trial. The safety and tolerability trial is eight weeks long, double blind, placebo controlled dose escalation trial of B-FAHF-2 in subjects who responded to induction therapy with Entocort EC. This portion of the study will serve to ensure safety and tolerability of B-FAHF-2. Subjects will be seen every 2 weeks and contacted by phone in between study visits to assess for any adverse events (AEs). This will be followed by a 6 month long, open-label exploratory extension trial of B-FAHF-2 monotherapy to ensure the sub-chronic safety as well as determine of there is any efficacy or immunologic alteration to pursue in randomized efficacy trials. During this phase, subjects will have follow-up visits every 4 weeks to assess for AEs and efficacy outcomes. In addition, a subset of 4 subjects will participate in PK studies for one of the visits during this phase. The exploratory efficacy phase of the study will be conducted in a population of subjects naive to immunomodulators, systemic steroids and biologics. This study population will provide us with an opportunity to determine the safety and immunologic effects of B-FAHF-2 in CD without the interference of systemic immunomodulating medications.
Low dose BFAHF-2 (29 mg/kg/d divided two times a day) for 2 weeks followed by a full dose (71mg/kg/d divided two times a day) for 6 weeks
Placebo Comparator: Placebo
tablets are identical in appearance to BFAHF-2 tablets
Drug: - BFAHF-2
BFAHF-2 is a 0.55g circular tablet that is easy to swallow with a diameter of 0.44 inches and a thickness of 0.19 inches. The quality, safety and consistency of BFAHF-2 are established per FDA guidance under a botanical drug title. Low dose (maximum of 2 tablets bid) and full dose (maximum of 5 tablets bid). Weight based dosing will ensure an equivalent amount is given to each individual.
Drug: - Placebo
Placebo tablets made of cornstarch
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